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Ocrelizumab

Generic Name
Ocrelizumab
Brand Names
Ocrevus
Drug Type
Biotech
CAS Number
637334-45-3
Unique Ingredient Identifier
A10SJL62JY
Background

Ocrelizumab is a CD20-directed cytolytic antibody indicated for the treatment of patients with primary progressive or relapsing forms of multiple sclerosis (MS). It is a second-generation recombinant humanized monoclonal IgG1 antibody that selectively targets B-cells that express the CD20 antigen. Compared to non-humanized CD20 antibodies such as rituximab, ocrelizumab is expected to be less immunogenic with repeated infusions, improving the benefit-to-risk profile for patients with MS.

MS is a chronic, inflammatory, autoimmune disease of the central nervous system that leads to neurological disabilities and a significantly reduced quality of life. Most patients with MS experience episodes of relapses with worsening function, followed by recovery periods or remissions. Primary progressive multiple sclerosis (PPMS) accounts for 10-15% of the overall population of patients with MS, and leads to the gradual worsening of neurologic disability from symptom onset, often without early relapses or remissions .

Developed by Genentech/Roche, ocrelizumab was approved by the FDA in March 2017 under the market name Ocrevus for intravenous injection. It was later approved by Health Canada in August 2017, making the drug the first available treatment for PPMS in both the US and Canada. In clinical trials of patients with relapsing forms of MS, treatment with ocrelizumab resulted in reduced relapse rates and reduced worsening of disability compared to interferon beta-1a. In phase 3 clinical trials of patients with PPMS, treatment with ocrelizumab led to lower clinical and MRI progression rates compared to placebo.

Indication

用于治疗复发型多发性硬化症(MS)。

Associated Conditions
Clinically Isolated Syndrome (CIS), Primary Progressive Multiple Sclerosis (PPMS), Relapsing Multiple Sclerosis (RMS), Relapsing Remitting Multiple Sclerosis (RRMS), Active Secondary Progressive Multiple Sclerosis (SPMS)

A Study to Evaluate Ocrelizumab Compared With Placebo in Patients With Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate Therapy

Phase 3
Terminated
Conditions
Rheumatoid Arthritis
Interventions
First Posted Date
2008-05-07
Last Posted Date
2020-12-04
Lead Sponsor
Genentech, Inc.
Target Recruit Count
314
Registration Number
NCT00673920

A Study to Evaluate Ocrelizumab in Patients With Nephritis Due to Systemic Lupus Erythematosus (BELONG)

Phase 3
Terminated
Conditions
Systemic Lupus Erythematosus
Lupus Nephritis
Interventions
First Posted Date
2008-02-29
Last Posted Date
2020-12-22
Lead Sponsor
Genentech, Inc.
Target Recruit Count
381
Registration Number
NCT00626197

A Study to Evaluate Two Doses of Ocrelizumab in Patients With Active Systemic Lupus Erythematosus (BEGIN)

First Posted Date
2007-10-05
Last Posted Date
2020-09-17
Lead Sponsor
Genentech, Inc.
Target Recruit Count
33
Registration Number
NCT00539838

A Study of Ocrelizumab in Combination With Methotrexate in Patients With Rheumatoid Arthritis Who Are Naive to Methotrexate (FILM)

Phase 3
Terminated
Conditions
Rheumatoid Arthritis
Interventions
First Posted Date
2007-06-13
Last Posted Date
2020-11-03
Lead Sponsor
Genentech, Inc.
Target Recruit Count
613
Registration Number
NCT00485589

A Study of Ocrelizumab Compared to Placebo in Patients With Active Rheumatoid Arthritis Who Don't Have a Response to Anti-TNF-α Therapy (SCRIPT)

Phase 3
Terminated
Conditions
Rheumatoid Arthritis
Interventions
First Posted Date
2007-05-22
Last Posted Date
2019-08-12
Lead Sponsor
Genentech, Inc.
Target Recruit Count
836
Registration Number
NCT00476996
Locations
🇺🇸

Pinnacle Research Group; Llc, Central, Anniston, Alabama, United States

🇺🇸

Center For Arthritis & Osteoporosis, Elizabethtown, Kentucky, United States

🇺🇸

Arthritis Consultants, Saint Louis, Missouri, United States

and more 261 locations

A Study of Ocrelizumab Compared to Placebo in Patients With Active Rheumatoid Arthritis Continuing Methotrexate Treatment (STAGE)

Phase 3
Terminated
Conditions
Rheumatoid Arthritis
Interventions
First Posted Date
2006-12-04
Last Posted Date
2020-11-27
Lead Sponsor
Genentech, Inc.
Target Recruit Count
1015
Registration Number
NCT00406419
Locations
🇺🇸

Trial Information Support Line, South San Francisco, California, United States

A Study to Evaluate the Safety of Escalating Doses of Ocrelizumab in Subjects With Rheumatoid Arthritis

Phase 1
Completed
Conditions
Rheumatoid Arthritis
First Posted Date
2004-02-16
Last Posted Date
2009-09-03
Lead Sponsor
Genentech, Inc.
Target Recruit Count
237
Registration Number
NCT00077870
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